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Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Adenocarcinoma of Prostate
Prostate Cancer

Treatments

Drug: Mifepristone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Full description

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Enrollment

48 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologic documentation of adenocarcinoma of the prostate
  • Bone metastasis(es) by bone scan or cat scan
  • Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
  • One prior chemotherapy treatment is allowed.
  • > 3 weeks since major surgery
  • > 4 weeks since radiotherapy
  • > 8 weeks since prior strontium-89 or samarium 153
  • ECOG performance status 0 or 1
  • Absolute neutrophil count (ANC) > 1,500/ul
  • Platelets > 100,000/ul
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • AST or ALT < 3 x ULN
  • Creatinine < 1.5 x ULN
  • Electrolytes within 10% of normal range
  • Serum testosterone < 50ng/dL
  • Prostate-specific antigen (PSA) > 5.0ng/ml

Exclusion criteria

  • Concomitant therapy with corticosteroids
  • Chemotherapy within 28 days
  • Currently active second malignancy other than non-melanoma skin cancer
  • Baseline adrenal insufficiency requiring long-term steroids

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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